Key result
High-dose fospropofol achieves rapid sedation in ~100% of patients but causes deep sedation and delayed recovery.
Why the study?
The FDA-approved fospropofol dose regimen is minimally effective with slow onset and often requires supplemental doses and early re-dosing for adequate sedation.
Does a 10 mg/kg bolus of fospropofol improve sedation success compared to 6.5 mg/kg or placebo in adults undergoing regional anesthesia for orthopedic surgery?
RCT (n=12)
randomly assigned
Does a 10 mg/kg bolus of fospropofol improve sedation success compared to 6.5 mg/kg or placebo in adults undergoing regional anesthesia for orthopedic surgery?
A 10 mg/kg bolus of fospropofol achieves rapid sedation but is associated with deep sedation and apnea, making it unsuitable for procedures requiring minimal-to-moderate sedation.
Answers are grounded in this paper and cite their sources.
10 mg/kg fospropofol risks deep sedation and delayed recovery; cautions against higher dosing for moderate sedation and extends RCT evidence on fospropofol titration.
Objective: Fospropofol disodium (Lusedra®) is a pro-drug propofol for Monitored Anesthesia Care. The FDA-approved dose regimen is minimally effective with a slow onset often requiring supplemental doses at 4 minutes to achieve adequate sedation and frequently requires early re-dosing. This study was designed to assess if a larger initial bolus dose of 10 mg/kg could achieve successful sedation without supplemental doses and without an increase in sedation-related adverse events. Methods: An IRB-approved trial enrolled 12 adults undergoing elective orthopedic surgery with regional block. After IV fentanyl 50-75 micrograms, patients were randomly assigned into three IV bolus groups: fospropofol 6.5 mg/kg, fospropofol 10 mg/kg, or placebo with midazolam for rescue sedation if needed. Following the initial bolus, the level of sedation was measured, and, if adequate, the block initiated or additional IV sedation injected before proceeding with the block. Results: 100% of the 10 mg/kg fospropofol group achieved appropriate sedation in less than 4 minutes compared to 50% of the 6.5 mg/kg group (P=0.048) and 40% of the fentanyl only participants with average times to sedation of 2.0 ± 0.0 minutes, 5.0 ± 4.0 minutes, and 7.0 ± 6.0 minutes, respectively. All of the 10 mg/kg group experienced deep sedation (MOAA/S 1-2), 60% experienced paresthesia or pruritus on bolus injection, 40% experienced delayed recovery from sedation, and 20% (1 of 5 patients) experienced a short period of apnea without hypoxemia. Sedation with midazolam produced delayed recovery in 40% of patients and 20% experienced deep sedation (MOAA/S 1-2). Conclusion: 10 mg/kg bolus-dose fospropofol was 100% successful in producing sedation in less than 4 minutes, but was accompanied by deep sedation (p+0.048) and delayed recovery from sedation and more frequent apnea that make this dose unsuitable for procedures requiring short or minimal-to-moderate sedation. Further randomized trials with adequate power are required including consideration of an 8 mg/kg dose of fospropofol for MAC sedation procedures.
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L et al. (2015) conducted an RCT in Elective orthopedic surgery with regional block (n=12). Fospropofol disodium vs. 6.5 mg/kg fospropofol or placebo with midazolam was evaluated on Appropriate sedation in less than 4 minutes (p=0.048). A 10 mg/kg bolus of fospropofol achieved appropriate sedation in <4 minutes in 100% of patients versus 50% with 6.5 mg/kg (P=0.048), but was accompanied by deep sedation and delayed recovery.
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